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A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

Recruiting
55-75 years
All
Phase 2

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Overview

The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.

Eligibility

Inclusion Criteria:

  • Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
  • Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
  • Mini Mental State Examination (MMSE) greater than or equal to (>=) 27 (with educational adjustment)
  • Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
  • A participant must be of non-childbearing potential

Exclusion Criteria:

  • History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
  • Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy
  • Diagnosis of Mild Cognitive Impairment (MCI)
  • Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment
  • History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

Study details
    Preclinical Alzheimer's Disease

NCT06544616

Janssen Pharmaceutica N.V., Belgium

31 July 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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